Impact of the 2014 Food and Drug Administration Warnings Against Power Morcellation.

Abstract

STUDY OBJECTIVE To determine whether members of the AAGL Advancing Minimally Invasive Gynecologic Surgery Worldwide (AAGL) and members of the American College of Obstetricians and Gynecologists Collaborative Ambulatory Research Network (ACOG CARN) have changed their clinical practice based on the 2014 Food and Drug Administration (FDA) warnings against power morcellation. DESIGN A survey study. SETTING Participants were invited to complete this online survey (Canadian Task Force classification II-2). PATIENTS AAGL and ACOG CARN members. INTERVENTIONS An online anonymous survey with 24 questions regarding demographics and changes to clinical practice during minimally invasive myomectomies and hysterectomies based on the 2014 FDA warnings against power morcellation. MEASUREMENTS AND MAIN RESULTS A total of 615 AAGL members and 54 ACOG CARN members responded (response rates of 8.2% and 60%, respectively). Before the FDA warnings, 85.8% and 86.9%, respectively, were using power morcellation during myomectomies and hysterectomies. After the FDA warnings, 71.1% and 75.8% of respondents reported stopping the use of power morcellation during myomectomies and hysterectomies. The most common reasons cited for discontinuing the use of power morcellation or using it less often were hospital mandate (45.6%), the concern for legal consequences (16.1%), and the April 2014 FDA warning (13.9%). Nearly half of the respondents (45.6%) reported an increase in their rate of laparotomy. Most (80.3%) believed that the 2014 FDA warnings have not led to an improvement in patient outcomes and have led to harming patients (55.1%). CONCLUSION AAGL and ACOG CARN respondents reported decreased use of power morcellation during minimally invasive gynecologic surgery after the 2014 FDA warnings, the most common reason cited being hospital mandate. Rates of laparotomy have increased. Most members surveyed believe that the FDA warnings have not improved patient outcomes.

DOI: 10.1016/j.jmig.2016.01.019

Cite this paper

@article{Lum2016ImpactOT, title={Impact of the 2014 Food and Drug Administration Warnings Against Power Morcellation.}, author={Deirdre A Lum and Eric R. Sokol and Jonathan S. Berek and Jay Schulkin and Ling Chen and Cora-Ann Mcelwain and Jason Dennis Wright}, journal={Journal of minimally invasive gynecology}, year={2016}, volume={23 4}, pages={548-56} }